Pediatric Deep Brain Stimulation for Therapy and Neuroenhancement: Ethical, Clinical and Legal Dimensions

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Published: Mar 26, 2025
DOI: https://doi.org/10.12681/bioeth.40930
Keywords:
pediatric DBS therapy neuroenhancement ethics clinical trials regulations
Melpomeni Minagia
Medical Student, University of Athens, Greece, and Intern, National Commission for Bioethics & Technoethics, Greece.
Abstract

Deep Brain Stimulation (DBS) is traditionally applied in adults for the therapy of certain neurological and psychiatric disorders. Except for adults, it can also be implemented in children, but its applications in pediatrics are limited. A groundbreaking scenario regarding the future of DBS is its potential use beyond the restoration of human health, in the field of neuroenhancement. However, the new applications of DBS present serious ethical, clinical, and legal concerns, which are examined in this paper.


In the beginning, the applications of pediatric DBS are presented, along with the method’s potential short- and long-term effects. Subsequently, the concept of “neuroenhancement”, contrasted with “therapy”, and the potential role of pediatric DBS in this domain are analyzed. Moving on to the ethical considerations of pediatric DBS, a wide range of topics are covered, involving safety issues, authenticity, decision-making, and social concerns. In the section on clinical dimensions, the importance of conducting relevant clinical trials as well as their challenges are elucidated. Afterward, as the legal framework of DBS devices is examined, regulations both for medical and non-medical devices are provided, depending on the specific DBS application. These discussions serve as a preparation for the proposal of recommendations, from an ethical, clinical, and legal perspective. 


The overall purpose of this paper is to provide pathways for the alignment of scientific advancement with the welfare of children.

Article Details
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References
Krauss JK, Lipsman N, Aziz T, Boutet A, Brown P, Chang JW, Davidson B, Grill WM, Hariz MI, Horn A, Schulder M, Mammis A, Tass PA, Volkmann J, Lozano AM. (2021). Technology of deep brain stimulation: current status and future directions. Nature Reviews Neurology, 17(2): 75-87. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7116699/
Pugh J, Pycroft L, Sandberg A, Aziz T, Savulescu J. (2018). Brainjacking in deep brain stimulation and autonomy. Ethics and Information Technology, 20(3): 219–232. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6290799/
DiFrancesco MF, Halpern CH, Hurtig HH, Baltuch GH, Heuer GG. (2012). Pediatric indications for deep brain stimulation. Child’s Nervous System, 28: 1701–1714. Available at: https://link.springer.com/article/10.1007/s00381-012-1861-2
Kostick-Quenet K, Kalwani L, Koenig B, Torgerson L, Sanchez C, Munoz K, Hsu RL, Sierra-Mercado D, Robinson JO, Outram S, Pereira S, McGuire A, Zuk P, Lazaro-Munoz G. (2022). Researchers’ Ethical Concerns About Using Adaptive Deep Brain Stimulation for Enhancement. Frontiers in Human Neuroscience, 16. Available at: https://www.frontiersin.org/articles/10.3389/fnhum.2022.813922/full
Gorodetsky C, Fasano A. (2022) Approach to the Treatment of Pediatric Dystonia. Dystonia, 1. Available at: https://www.researchgate.net/publication/362417043_Approach_to_the_Treatment_of_Pediatric_Dystonia
Cif L, Coubes P. (2017). Historical developments in children's deep brain stimulation. European Journal of Paediatric Neurology, 21(1): 109-117. Available at: https://www.ejpn-journal.com/article/S1090-3798(16)30144-1/fulltext
Rouhani E, Jafari E, Akhavan A. (2023). Suppression of seizure in childhood absence epilepsy using robust control of deep brain stimulation: a simulation study. Scientific Reports, 13: 461. Available at: https://www.nature.com/articles/s41598-023-27527-1#citeas
Halpern CH, Samadani U, Litt B, Jaggi JL, Baltuch GH. (2008). Deep Brain Stimulation for Epilepsy. Neurotherapeutics, 5(1): 59-67. Available at: https://www.academia.edu/72523872/Deep_brain_stimulation_for_epilepsy?sm=b
Gadgil N, Muir M, Lopresti MA, Lam SK. (2019). An update on pediatric surgical epilepsy: Part II. Surgical Neurology International, 10: 258. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6935971/
Shafer Obsorne P. (2018, May 1). FDA Approval: Medtronic Deep Brain Stimulation for Medically Refractory Epilepsy. Epilepsy Foundation. https://www.epilepsy.com/stories/fda-approval-medtronic-deep-brain-stimulation-medically-refractory-epilepsy
Weinzimmer SA, Schneider SC, Cepeda SL, Guzick AG, Lázaro-Muñoz G, McIngvale E, Goodman WK, Sheth SA, Storch EA. (2021). Perceptions of Deep Brain Stimulation for Adolescents with Obsessive-Compulsive Disorder. Journal of Child and Adolescent Psychopharmacology, 31(2): 109–117. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7984933/
Muñoz KA, Kostick K, Torgerson L, Zuk P, Kalwani L, Sanchez C, Blumenthal-Barby J, Storch EA, Lázaro-Muñoz G. (2021). Pressing ethical issues in considering pediatric deep brain stimulation for obsessive-compulsive disorder. Brain Stimulation Journal, 14(6): 566-1572. Available at: https://www.brainstimjrnl.com/article/S1935-861X(21)00634-3/fulltext
Alcindor D, Oh MY, Baser S, Angle C, Cheng BC, Whiting D. (2010). Stimulation of the globus pallidus internus in a patient with DYT1-positive primary generalized dystonia: a 10-year follow-up. Neurosurgical Focus, 29(2). Available at: https://thejns.org/focus/view/journals/neurosurg-focus/29/2/2010.6.focus10112.xml?tab_body=pdf-27560
Heinrich JH, Rüther M, Stake M, Ihde J. (2022). Neuroenhancement (1st ed., Vol. 21, pp. 13–116). Verlag Karl Alber. Available at: https://www.nomos-elibrary.de/10.5771/9783495999615/neuroenhancement
Campos PE. Ethical and legal implications of neuro-enhancement: New concerns and future perspectives. Available at: https://www.academia.edu/41439614/Ethical_and_legal_implications_of_neuro_enhancement_New_concerns_and_future_perspectives
Antal A, Luber B, Brem AK, Bikson M, Brunoni AR, Cohen Kadosh R, Dubljević V, Fecteau S, Ferreri F, Flöel A, Hallett M, Hamilton RH, Herrmann CS, Lavidor M, Loo C, Lustenberger C, Machado S, Miniussi C, Moliadze V, Nitsche MA. (2022). Non-invasive brain stimulation and neuroenhancement. Clinical Neurophysiology Practice, 7: 146–165. Available at: https://www.sciencedirect.com/science/article/pii/S2467981X2200021X
Buchanan A. (2011). Cognitive enhancement and education. Theory and Research in Education, 9(2): 145–162. Available at: https://www.academia.edu/93160647/Cognitive_enhancement_and_education
Marazziti D, Avella MT, Ivaldi T, Palermo S, Massa L, Vecchia AD, Basile L, Mucci F. (2021). Neuroenhancement: State of the Art and Future Perspectives. Clinical Neuropsychiatry, 18(3): 137-169. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8629054/
Amoah DK. (2022). Advances in the understanding and enhancement of the human cognitive functions of learning and memory. Brain Science Advances, 8(4): 276–297. Available at: https://journals.sagepub.com/doi/full/10.26599/BSA.2022.9050023
Schermer M. (2011). Health, Happiness and Human Enhancement—Dealing with Unexpected Effects of Deep Brain Stimulation. Neuroethics, 6(3): 435–445. Available at: https://link.springer.com/article/10.1007/s12152-011-9097-5
Pacholczyk A. (2011). DBS makes you feel good! – why some of the ethical objections to the use of DBS for neuropsychiatric disorders and enhancement are not convincing. Frontiers in Integrative Neuroscience, 5(14). Available at: https://www.academia.edu/99348954/DBS_Makes_You_Feel_Good_Why_Some_of_the_Ethical_Objections_to_the_Use_of_DBS_for_Neuropsychiatric_Disorders_and_Enhancement_are_Not_Convincing
Davidson B, Elkaim LM, Lipsman N, Ibrahim GM. (2018). Editorial. An ethical framework for deep brain stimulation in children. Neurosurgical Focus, 45(3). Available at: https://thejns.org/focus/view/journals/neurosurg-focus/45/3/article-pE11.xml
Pycroft L, Boccard SG, Owen SLF, Stein JF, Fitzgerald JJ, Green AL, Aziz TZ. Brainjacking: implant security issues in invasive neuromodulation. Available at: https://www.academia.edu/50513814/Brainjacking_implant_security_issues_in_invasive_neuromodulation
Johansson V, Garwicz M, Kanje M, Halldenius L, Schouenborg J. (2014). Thinking Ahead on Deep Brain Stimulation: An Analysis of the Ethical Implications of a Developing Technology. AJOB Neuroscience, 5(1): 24–33. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3933012/
Storch, EA, Cepeda SL, Lee E, Goodman SLV, Robinson AD, De Nadai AS, Schneider SC, Sheth SA, Torgerson L, Lázaro-Muñoz G. (2019). Parental Attitudes Toward Deep Brain Stimulation in Adolescents with Treatment-Resistant Conditions. Journal of Child and Adolescent Psychopharmacology, 30(2): 97-103. Available at: https://www.liebertpub.com/doi/10.1089/cap.2019.0134
Polakova K, Ahmed F, Vlckova K, Brearley SG. (2023) Parents' experiences of being involved in medical decision-making for their child with a life-limiting condition: A systematic review with narrative synthesis. Palliative Medicine, 38(1):7-24. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10798032/
Joseph PD, Craig JC, Caldwell PH. (2015). Clinical trials in children. British Journal of Clinical Pharmacology, 79(3): 357–369. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4345947/
Jain A, Ganesh N, Venkatesh MP. (2014). Quality Standards for Medical Devices. International Journal of Drug Regulatory Affairs, 2(4):19-24. Available at: https://www.academia.edu/103231835/Quality_Standards_for_Medical_Devices?sm=b
Bansal S. Medical device regulations in European union. Available at: https://www.academia.edu/43072906/Medical_device_regulations_in_European_union?sm=b
Premarket Approval (PMA). (2019, May 16). U.S. Food And Drug Administration. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma
Humanitarian Device Exemption. (2022, October 3). U.S. Food And Drug Administration. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/humanitarian-device-exemption
Fact Sheet: Pediatric provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA). (2018, March 28). U.S. Food And Drug Administration. https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/fact-sheet-pediatric-provisions-food-and-drug-administration-safety-and-innovation-act-fdasia
FAQs about Investigational Device Exemption. (2024, May 9). U.S. Food And Drug Administration. https://www.fda.gov/medical-devices/investigational-device-exemption-ide/faqs-about-investigational-device-exemption#labeling
Hwang TJ, Kesselheim AS, Bourgeois FT. (2014). Postmarketing trials and pediatric device approvals. Pediatrics, 133(5): 1197-1202. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4531281/
Team-NB Position Paper TEAM-NB Data generated from “Off-Label” Use of a device under the EU Medical Device Regulation 2017/745. (2022). https://www.team-nb.org/wp-content/uploads/2022/10/Team-NB-PositionPaper-Off-LabelUse-V1-20221005.pdf
FDA approves Medtronic PerceptTM RC neurostimulator with exclusive BrainSenseTM technology. (2024, January 8). Medtronic News. https://news.medtronic.com/2024-01-08-FDA-approves-Medtronic-Percept-TM-RC-neurostimulator-with-exclusive-BrainSense-TM-technology
Medtronic receives FDA approval of Percept RC DBS system. (2024, January 11). Med-Tech Innovation. https://www.med-technews.com/news/medical-device-news/medtronic-receives-fda-approval-of-precept-rc-dbs-system/
Medtronic receives CE Mark for the Percept RC rechargeable DBS neurostimulator with BrainSense technology. (2023, December 5). Medtronic News. https://news.medtronic.com/2023-12-05-Medtronic-receives-CE-Mark-for-the-Percept-RC-rechargeable-DBS-neurostimulator-with-BrainSense-technology
Devices without an intended medical purpose - Annex XVI devices. (2022, December 19). Www.johner-Institute.com. https://www.johner-institute.com/articles/regulatory-affairs/devices-without-an-intended-medical-purpose-annex-xvi-devices/